Trial regulation in emerging markets is now "too stringent," says new report

Regulation of clinical trials in emerging markets is now too strict and is prompting sponsors and CROs to adopt “one-size-fits-all” designs, according to a new study.

In the report, Trudie Lang and Sisira Siribaddana of University of Oxford’s Centre for Tropical Medicine, UK, said that “too-rigorous” regulatory requirements have left pharma firms and CROs (contract research organisations) afraid to tailor trials in developing areas to suit their specific risks and complexities.

And though emerging markets were once avoided because of a lack of protocol, they said that now too-severe trial processes are causing researchers to be over cautious.

Lang and Siribaddana also said it could lead to a drop-off in the amount of trials in those regions – once attractive because they are cheaper than Western studies – because the resulting raised costs of extra layers of bureaucracy are off-putting.

“Few would argue with the importance of well-regulated clinical trials to ensure high ethical standards and that trial conduct and processes are producing valid and accurate data,” the authors wrote.

“However, there is a call for making trial regulation less complicated and more readily adaptable to risk, and for having guidelines that are globally applicable and adaptable to all types of trial.”

“Overly zealous”

But the report – titled ‘Clinical Trials Have Gone Global: Is This a Good Thing?’ – does not lay the blame solely on the regulators’ doorstep.

Lang and Siribaddana said that often guidelines have more leeway than the sponsor or CRO expects, but that they do not put enough trust into locally run research sites.

They wrote: “In developing countries it is our experience that external sponsors and their locally appointed CROs are often overly zealous in their interpretation of trial guidelines and apply a one-size-fits-all approach to trial coordination and monitoring, irrespective of the risk and complexity.

“This is often due to an inaccurate perception from the sponsor and CRO about the ability of the research sites to run high quality and compliant trials.”

The solution

The study, published in PLoS Medicine, suggests there is a need for more knowledgeable research teams who have the experience to challenge overly stringent requirement, which otherwise “remain in place and become the expected norm for every clinical research study.”

The need for higher income research communities to encourage investigators from poorer markets to conduct their own trials also ranked high on the to-do list.

By providing the incentives and mandates, the research sector in those countries would be boosted and hence it would be easier to place trust in those sites, the report said.

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